The US Food and Drug Administration (FDA) has approved Imjudo (tremelimumab-actl) in combination with Imfinzi (durvalumab) and platinum-based chemotherapy for the treatment of adults with metastatic non-small cell lung cancer (NSCLC) with no sensitizing EGFR mutations or ALK genomic tumor aberrations.
The approval was based on data from the open-label, phase 3 POSEIDON study (ClinicalTrials.gov Identifier: NCT03164616), which was designed to evaluate the efficacy and safety of tremelimumab plus durvalumab and platinum-based chemotherapy in 675 patients with metastatic NSCLC who had not received prior systemic therapy.
Patients were randomly assigned 1:1:1 to receive tremelimumab plus durvalumab and platinum-based chemotherapy; durvalumab plus platinum-based chemotherapy; or platinum-based chemotherapy. The primary endpoints were progression-free survival (PFS) and overall survival (OS).
Treatment with tremelimumab plus durvalumab and platinum-based chemotherapy demonstrated a statistically significant and clinically meaningful improvement in OS compared with platinum-based chemotherapy (hazard ratio [HR], 0.77; 95% CI, 0.65-0.92; 2-sided P =.00304). The median OS was 14 months and 11.7 months, respectively.
A statistically significant and clinically meaningful improvement in PFS was observed with tremelimumab plus durvalumab and platinum-based chemotherapy compared with platinum-based chemotherapy (HR, 0.72; 95% CI, 0.60-0.86; 2-sided P =.00031). The median PFS was 6.2 months and 4.8 months, respectively.
The most common adverse events reported were nausea, fatigue, decreased appetite, musculoskeletal pain, rash, and diarrhea. The most common grade 3-4 events were neutropenia, anemia, leukopenia, lymphocytopenia, increased lipase, hyponatremia, and thrombocytopenia.
Imjudo is also indicated in combination with Imfinzi for the treatment of adults with unresectable hepatocellular carcinoma.
- FDA approves tremelimumab in combination with durvalumab and platinum-based chemotherapy for metastatic non-small cell lung cancer. News release. US Food and Drug Administration. Accessed November 10, 2022. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-tremelimumab-combination-durvalumab-and-platinum-based-chemotherapy-metastatic-non
- Imfinzi and Imjudo with chemotherapy approved in the US for patients with metastatic non-small cell lung cancer. News release. November 11, 2022. https://www.businesswire.com/news/home/20221111005248/en/IMFINZI-and-IMJUDO-with-chemotherapy-approved-in-the-US-for-patients-with-metastatic-non-small-cell-lung-cancer
- Imjudo. Package insert. AstraZeneca; 2022. Accessed November 10, 2022. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761270s000lbl.pdf
This article originally appeared on MPR